Fresenius Kabi Recalls Midazolam Hydrochloride Injection Vials Due to Sterility Concerns
Fresenius Kabi USA is recalling 101,200 vials of Midazolam Hydrochloride Injection due to potential glass fractures and particles that compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving potential contamination (glass particles) that could lead to adverse health consequences are categorized as Severe (Score 4), as they represent a significant risk of injury or property damage, though not necessarily death or serious permanent injury.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 101,200 vials of Midazolam Hydrochloride Injection, 5 mg/1 mL. The affected product is Lot 6003827 with an expiration date of 04/2015. The recall was initiated because glass vials may have finish fractures and glass particles, which creates a lack of assurance of sterility.
The recalled product was distributed nationwide in the United States, including Puerto Rico. The product is a prescription-only medication intended for intramuscular or intravenous use. The manufacturer is Fresenius Kabi USA, LLC, and the product is associated with APP Pharmaceuticals, LLC in Schaumburg, IL.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on how to return the product. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
- Brand
- MIDAZOLAM
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Affected units
- 101,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 6003827
- Exp. Date 04/2015
UPCs (7)
- 0363323411183
- 0363323411138
- 0363323412135
- 0363323411220
- 0363323412180
- 0363323412036
- 0363323411152
Distribution
Part of a larger recall action
This product is one of 3 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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